Cleared Traditional

K141701 - I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]

K141701 is an FDA 510(k) clearance for I-125 RSLN [RADIOACTIVE SEED AND LOCALI..., manufactured by Isoaid, LLC. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K141701 · Isoaid, LLC · Radiology device
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Dec 2014
Decision
164d
Days
Class 2
Risk

K141701 is an FDA 510(k) clearance for the I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoaid, LLC (Port Richey, US). The FDA issued a Cleared decision on December 5, 2014 after a review of 164 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Isoaid, LLC devices

FDA 510(k) Submission Details - K141701

510(k) Number K141701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2014
Decision Date December 05, 2014
Days to Decision 164 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 128
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K141701.
SPEC Model M16
K150895 · Source Production and Equipment Co., Inc. · Jun 2015
VariSeed 9.0
K150636 · Varian Medical Systems, Inc. · May 2015
SMD Sr90-1 Radionuclide Brachytherapy Source
K142701 · Salutaris Medical Devices, Inc. · Dec 2014
Lesion-Loc Iodine I-125 Seed/Needle
K142668 · Intramedical Imaging, LLC · Nov 2014
ANT MODEL 1
K141038 · Advanced Nuclide Technologies, LLC · Nov 2014
CIVA SHEET PD-103
K140490 · Civatech Oncology, Inc. · Aug 2014